Phase I and II trials of subcutaneously administered rIL-2, interferon alfa-2a, and fluorouracil in patients with metastatic renal carcinoma

Citation
T. Olencki et al., Phase I and II trials of subcutaneously administered rIL-2, interferon alfa-2a, and fluorouracil in patients with metastatic renal carcinoma, J CANC RES, 127(5), 2001, pp. 319-324
Citations number
20
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Onconogenesis & Cancer Research
Journal title
JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY
ISSN journal
0171-5216 → ACNP
Volume
127
Issue
5
Year of publication
2001
Pages
319 - 324
Database
ISI
SICI code
0171-5216(200105)127:5<319:PIAITO>2.0.ZU;2-K
Abstract
Purpose: A phase I followed by a phase II trial utilizing rIL-2, IFN alpha, and 5-FU were conducted in patients with unresectable and/or metastatic re nal cell carcinoma. Methods: Treatment consisted of: rIL-2 at 5.0 x 10(6) I U/m(2) SQ on days 1-5 for 4 weeks, rHuIFN alpha -2a at 5.0 x 10(6) U/m(2) S Q on days 1, 3. and 5 for 4 weeks: and 5-FU by IV bolus on days 1-5 during week 1. In the phase I study patients were treated at varying doses of 5-FU : I-none, II-250 mg/m(2), 111-300, and IV 375. A phase II trial was then co nducted utilizing the same schedule and maximum tolerated dose (MTB) for 5- FU. Results: Twenty patients were entered into the phase I trial. Dose-limi ting toxicity included grade III nausea and vomiting, and one sudden cardia c death. The MTD for 5-FU was determined to be 300 mg/m(2). In the phase II trial, a median of two cycles of therapy was administered to 25 evaluable patients. Toxicity was moderate and consisted primarily of fevers, chills, fatigue, nausea: vomiting, and anorexia. Grade IV thrombocytopenia, consist ent with ITP, developed in one patient each on the phase I and phase II tri al. Seven partial responses were seen among 25 patients treated in the phas e II trial for a 28% (CI 12-49%) response rate. Conclusions: The addition o f 5-FU to rIL-2 and rHuIF alpha -2a appears to increase the toxicity of thi s therapy. Randomized trials will be required to determine if efficacy is e nhanced.